System and method for performing medical research across a vast patient population

ABSTRACT

A system and method for performing medical research over an extended computer network is disclosed. The system and method comprise a plurality of Electronic Health Record (EHR) systems configured to capture patient data for a plurality of general patients at a plurality of corresponding healthcare provider sites during encounters with those patients, a research system configured to generate one or more electronic documents for completion with patient data that is related to the medical research, and an enhanced services server built on the same architecture as the plurality of EHR systems, wherein the one or more electronic documents include one or more first fields and one or more second fields for completion with patient data that is related to the medical research and the enhanced services server is in electronic data communication with the plurality of EHR systems and the one or more research systems via a network connection. Qualifying patients are identified from among the plurality of general patients and the first fields in each of the electronic documents are automatically populated with patient data for a corresponding qualifying patient. The one or more electronic documents that were automatically populated with patient data is electronically transmitted to at least one EHR system via the network connection, and the at least one EHR system is used to complete the second fields in each of the electronic documents during subsequent patient encounters. The completed electronic documents are electronically transmitted from the at least one EHR system to the enhanced services server, which electronically transmits the completed electronic documents back to the research system via the network connection.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/392,998, filed Feb. 25, 2009, which is related to U.S. patentapplication Ser. No. 10/202,627, filed Jul. 25, 2002, and U.S. Pat. No.7,716,072, issued May 11, 2010, the entire contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to systems and methods of utilizing the datacaptured by an integrated medical software system. More particularly,the present invention relates to systems and methods of utilizing thedata captured in an integrated medical software system to conductmedical research, to maintain disease registries, to analyze the qualityand safety of healthcare providers, and to conduct composite clinicaland financial analytics.

BACKGROUND OF THE INVENTION

Traditionally, healthcare providers have kept all of their patients'information in paper filing systems. That patient information includes,but is not limited to, patients' demographic information (e.g., age,weight, gender, race, income, and geographic location) andhealth-related information (e.g., clinician documentation ofobservations, thoughts and actions, treatments administered, patienthistory, medication and allergy lists, vaccine administration lists,laboratory reports, X-rays, charts, progress notes, consultationreports, procedure notes, hospital reports, correspondence, and testresults). The healthcare providers that keep that patient informationinclude, but are not limited to, physicians—Doctor of Medicine (MD) orDoctor of Osteopathic Medicine (DO), dentists, chiropractors,podiatrists, therapists, psychologists, physician assistants, nurses,medical assistants, and technicians.

The manual, paper-based practice of keeping a patient's information,however, is a very inefficient, labor-intensive process requiring manychecks and balances to ensure accurate processing of the information andrequiring a significant amount of the healthcare provider's time thatcould otherwise be spent with the patient. Accordingly, electronicmedical records (EMRs), Electronic Health Records (EHRs), and PersonalHealth Records (PHRs) have been developed to provide many of thefunctionalities and features of paper filing systems in an electronic,paperless format. Systems using EMRs, EHRs, and PHRs have been developedto streamline clinical, financial, and administrative information; tostreamline workflow processes; and to improve coding and billingaccuracy.

An EMR is an electronic record of patient information that can becreated, gathered, managed, and consulted by the authorized cliniciansand staff at the specific healthcare provider that creates the record.An EHR is an electronic record of patient information that conforms tonationally recognized interoperability standards and that can becreated, managed, and consulted by authorized clinicians and staff atthe healthcare provider that creates the record as well as those atother healthcare provider sites. And, a PHR is an electronic record ofpatient information that conforms to nationally recognizedinteroperability standards and that can be drawn from multiple sourceswhile being managed, shared, and controlled by the patient to whom itbelongs. Accordingly, EMRs are aimed primarily at the efficientmanagement of multiple records in a single healthcare provider'spractice, while EHRs and PHRs are aimed primarily at integratingmultiple data sources into each electronic record.

The nationally recognized interoperability standards for EHRs arecurrently endorsed by the Healthcare Information Technology StandardsPanel (HTISP) and certified by the Certification Commission forHealthcare Information Technology (CCHIT). Those standards require EHRsto have the ability to communicate and exchange data accurately,effectively, securely, and consistently with different informationtechnology systems, software applications, and networks in varioussettings such that the clinical or operational purpose and meaning ofthe data are preserved and unaltered as that data is exchanged. Thus,while an EMR is generally characterized as an electronic version of aphysician's paper record, an EHR is characterized as a morecomprehensive record containing additional data integrated to and fromother sources. EHRs are further characterized as being either “basic” or“fully functional.” A basic EHR includes patient demographics, problemlists, clinical notes, orders for prescription, and viewing laboratoryand imaging results. A fully functional EHR includes patientdemographics, problem lists, clinical notes, medical history andfollow-up, orders for prescriptions, orders for tests, prescriptionorders sent electronically, laboratory and imaging results, warnings ofdrug interactions or contraindications, out-of-range test levels, andreminders for guideline-based interventions.

Most of the commercially available EMR and EHR systems, however, havenot been well received by healthcare providers. In fact, according to a2008 survey conducted by the National Center for Health Services (NCHS),a division of the Centers for Disease Control and Prevention (CDC),while about 40% of U.S. office-based physicians reported using EMRsystems, only 17% reported using basic EHR systems, and only 4% reportedusing fully functional EHR systems. Part of the problem with traditionalEHR systems is that many of the vendors of those systems have resistedmaking their software capable of exporting and importing patientinformation using uniform electronic messaging, document, and formmanagement standards (e.g., the Health Level Seven (HL7) messagingstandard, the Continuity of Care Document (CCD) document standard, andthe Retrieve Form for Data Capture (RFD) form management standard).

At their core, EMR and EHR systems include large-capacity databases thatcontain patient information stored in structured, relational tables ofsearchable data. But, when that data is not captured and stored usinguniform, standardized medical vocabularies and it is not transmittedusing uniform messaging, document, and form management standards, it isof little use outside of the system in which the data is stored unlesscustom interfaces are designed to connect that system to other systemsso that data can be shared therebetween. The process of developingdifferent interfaces between the disparate formats used by differentvendors is expensive and difficult. Moreover, the interfaces are alsocostly and labor-intensive to maintain.

The problem of interfacing different EHR systems is exacerbated by thefact that, in the present health care system, most patient visits are tosmall, self-contained practices that often treasure their autonomy andare unwilling and/or unable to acquire EHR systems unless each of thosesystems is individually tailored to the narrow objectives of eachspecific self-contained practice. Accordingly, most EHR vendors havebeen forced to provide healthcare providers with individually customizedsystems that employ stand-alone features and functions on the basis ofwhat a specific practice group wants and needs. Accordingly, similarpractice groups in adjacent counties may have very different systemfeatures and functions based on their different priorities. Thus, thevarious existing systems are not well suited for interaction and dataexchange with each other, or for maintaining information that would beuseful to the other systems, and the data collected by the differentpractice groups using EHR systems is therefore severely fragmented.

In addition, the enactment of the privacy and security regulations ofthe Health Insurance Portability and Accountability Act (HIPAA) hascaused major changes in the way physicians and medical centers operate.Implementation of those regulations increased the overall amount ofpaperwork and the overall costs required for healthcare providers tooperate. And, the complex legal implications associated with thoseregulations have caused concerns with compliance among healthcareproviders. With regard to researchers, the HIPAA regulations havehindered their ability to perform retrospective, chart-based research aswell as their ability to prospectively evaluate patients by contactingthem for follow-up surveys. The HIPAA regulations have also led tosignificant decreases in patient accrual, increases in time spentrecruiting patients, and increases in mean recruitment costs forresearchers. And, by requiring that informed consent forms for researchstudies include extensive detail on how the participant's protectedinformation will be kept private, those already complex documents havebecome even less user-friendly.

Because most EHR systems are not capable of exporting and importingpatient information in a standardized format and do not utilizefunctions and features suited for interaction and data exchange withother systems, the fragmented pools of data collected using thosesystems cannot easily be combined with the ocean of data collectedacross a population of patients, much less a community of patients.Accordingly, collecting data across a broad swath of patients to performmedical research, to maintain disease registries, to track patient carefor quality and safety initiatives, and to perform composite clinicaland financial analytics remains a time-consuming and expensive process.For example, a clinical research organization (CRO) tasked withidentifying patients that satisfy certain criteria for participating ina clinical trial must still sort through voluminous libraries of papermedical records and unstructured data, spending large amounts of timeand money searching for candidates. Those problems have only beenexacerbated by the regulations of HIPAA. Accordingly, there is a needfor a system and method of using a plurality of integrated EHR systemsto systematically analyze, collect, and track patient information acrossa vast patient population (e.g., a community, region, state, nation,etc.) while complying with HIPAA regulations in a more user-friendlymanner In addition, there is a need for a system and method thatutilizes that data to more effectively and efficiently perform clinicalresearch, maintain disease registries, track patient care for qualityand safety initiatives, and perform composite clinical and financialanalytics.

SUMMARY OF THE INVENTION

Accordingly, to solve at least the above problems and/or disadvantagesand to provide at least the advantages described below, a non-limitingobject of the present invention is to provide a system and method of foranalyzing, collecting, and tracking patient data across a vast patientpopulation comprising a plurality of Electronic Health Record (EHR)systems provided at a plurality of healthcare provider sites, each EHRsystem comprising at least one means for capturing data for a pluralityof patients in real time; comprising at least one research system forgenerating a dataset by performing at least one of analyzing,collecting, and tracking the data captured by the plurality of EHRsystems in real time as the data is captured or from a database on whichthe captured data is stored; and comprising at least one workstation forsetting the criteria by which the research system analyzes, collects andtracks the data captured by the plurality of EHR systems and for viewingthe dataset generated by the at least one research system, wherein thedataset includes the data that corresponds to each of the criteria setat the workstation.

Those and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the infrastructure of an integrated physician'snetwork according to a non-limiting embodiment of the present invention;

FIG. 2 is a schematic block diagram illustrating the functional steps ofa sequential filtering process according to a non-limiting embodiment ofthe present invention;

FIG. 3 is a schematic block diagram illustrating the functional steps ofa partner registration process according to a non-limiting embodiment ofthe present invention;

FIG. 4 is a schematic block diagram illustrating the functional steps ofa client registration process according to a non-limiting embodiment ofthe present invention; and

FIG. 5 is a schematic block diagram illustrating the functional steps ofpatient verification process according to a non-limiting embodiment ofthe present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Reference will now be made in detail to non-limiting embodiments of thepresent invention by way of reference to the accompanying drawings,wherein like reference numerals refer to like parts, components andstructures.

The present invention provides infrastructure and functionality foranalyzing, collecting, and tracking data across a vast patientpopulation. And, the present invention provides infrastructure andfunctionality for utilizing that data to more effectively andefficiently perform medical research, maintain disease registries, trackpatient care for quality and safety initiatives, and perform compositeclinical and financial analytics. The present invention may beimplemented via an integrated physician's infrastructure (IPI) 100 thatincludes a network of fully functional EHR systems that are built on thesame architecture, such as Greenway Medical Technologies, Inc.'s IPIthat includes its PRIMESUITE brand EHR systems. The IPI 100 alsoincludes a plurality of research systems built on the same architectureas the EHR systems so data can be shared seamlessly therebetween basedon integration rather than interfacing different systems together.

By integrating the infrastructure and architecture of the varioussystems of the IPI 100, the present invention provides a single-vendorsolution that allows for single-vendor support and the seamless sharingof standardized data across all of those systems. Accordingly, that datacan be actively analyzed, collected, and tracked across a vast patientpopulation in real time based on triggering events rather than requiringthat queries be run on passive, “stale” data housed in a datarepository. Moreover, by standardizing the format in which the data iscaptured and stored as well as the format by which it is exchangedacross all of the systems of the IPI 100, the need for “middleware” typearchitecture to interface the various systems is eliminated. Thus,errors, duplication, and inconsistencies in data are also eliminated bythe present invention. And, by building all of the systems of the IPI100 on the same architecture, each system can be upgraded as a singleentity with consideration for all functionality that may be affected.

Turning to the drawings, FIG. 1 illustrates an exemplary non-limitingembodiment of the infrastructure of the IPI 100 of the presentinvention. The IPI 100 is a network of computer systems comprising aplurality of EHR systems, a plurality of research systems, and at leastone IPI provider system that are interconnected via a plurality ofsecured connections. Each EHR system is provided at a healthcareprovider's site 102 and includes at least one client server 104 and atleast one client workstation 106. Each research system may be providedat a researcher's site 108 and includes at least one partner server 110and at least one partner workstation 112. And, each IPI provider systemmay be provided at the IPI provider's site 114 and includes at least oneenhanced services server 116 and at least one administrator workstation118. The EHR systems, research systems, and IPI provider system are allbuilt on the same architecture so that the various systems of the IPI100 and the functionality of each of their applications may beseamlessly integrated across the entire IPI 100.

The client server 104 of each EHR system contains all of the systemapplications and controls the operation of the EHR system. The clientserver 104 also controls communications with the other components of theIPI 100 and locally stores data collected using the EHR system. Theclient server 104 is at the center of the EHR system and may be locatedat a central location at a healthcare provider's site 102 forcommunication with each of the client workstations 106. In thealternative, as opposed to being hosted at the healthcare provider'ssite 102, all of the applications, controls, and data for the EHR systemmay be remotely hosted at a client server 120 located at a client datacenter 122. A client server 120 located at a client data center 122 mayalso host the applications, controls, and data for other EHR systemsutilized by different healthcare providers.

The client workstations 106 provide a point of communication betweenhealthcare providers and the client server 104 of the EHR system. Theclient workstations 106 of each EHR system may be provided at variouslocations, remote from the client server 104, throughout the healthcareprovider's site 102 (e.g., in different physicians' offices). When theclient server 104 is also located at the healthcare provider's site 102,the client workstations 106 communicate with the client server 104 andwith each other over a Local Area Network (LAN) via a client router 124.The client server 104 and client workstations 106 of each EHR systemalso communicate with the enhanced services server 116 and administratorworkstation 118 of the IPI provider system via a provider router 126provided at the IPI provider's site 114, which preferably communicateswith the client router 124 via a broadband network, such as DSL(“Digital Subscriber Line”), cable modem, or other high-speedconnection.

When the client server 120 is provided at the client data center 122,the client workstations 106 communicate with that client server 120 viaa client data center router 128 at the client data center 122 thatpreferably communicates with the client router 124 via a privatededicated network, such as a frame relay network. In that configuration,the client server 120 at the client data center 122 and the clientworkstations 106 at the healthcare provider's site 102 may alsocommunicate with the enhanced services server 116 and administratorworkstation 118 of the IPI provider system via the provider router 126provided at the IPI provider's site 114, which communicates both withthe client router 124 and the client data center router 128 via theprivate dedicated network. The client data center router 128 is locatedbehind a firewall 130 to provide security from unauthorized internetaccess. And, use of a private dedicated network to facilitate thetransmission of data when the client server 120 is provided at alocation remote from the location of the client workstations 106 causesthose components to perform like a private dedicated network andprovides additional security to that network. Although the exemplaryembodiment illustrated in FIG. 1 utilizes a broadband network when theclient server 104 is provided at the healthcare provider's site 102 anda private dedicated network when the client server 120 is provided atthe client data center 122, either a broadband network or a privatededicated network may be utilized in either configuration.

The partner server 110 of each research system contains all of thesystem applications and controls the operation of the research system.The partner server 110 also controls communications with the othercomponents of the IPI 100 and locally stores data collected using theresearch system. The partner server 110 is at the center of the researchsystem and may be located at a central location at a researcher's site108 for communication with each of the partner workstations 112. In thealternative, as opposed to being hosted at the researcher's site 108,all of the applications, controls, and data for the research system maybe remotely hosted at a partner server 132 located at a partner datacenter 134. A partner server 132 located at a partner data center 134may also host the applications, controls, and data for other researchsystems utilized by different healthcare providers.

The partner workstations 112 provide a point of communication betweenresearchers and the partner server 110 of the research system. Thepartner workstations 112 of each research system may be provided atvarious locations, remote from the partner server 110, throughout theresearcher's site 108 (e.g., in different researchers' offices). Whenthe partner server 110 is also located at the researcher's site 108, thepartner workstations 112 communicate with the partner server 110 andwith each other over a LAN via a partner router 136. The partner server110 and partner workstations 112 of each research system alsocommunicate with the enhanced services server 116 and administratorworkstation 118 of the IPI provider system via the provider router 126provided at the IPI provider's site 114, which preferably communicateswith the partner router 136 via a broadband network.

When the partner server 132 is provided at the partner data center 134,the partner workstations 112 communicate with that partner server 132via a partner data center router 138 at the partner data center 134 thatpreferably communicates with the partner router 136 via a privatededicated network. In that configuration, the partner server 132 at thepartner data center 134 and the partner workstations 112 at theresearcher's site 108 may also communicate with the enhanced servicesserver 116 and administrator workstation 118 of the IPI provider systemvia the provider router 126 provided at the IPI provider's site 114,which communicates both with the partner router 136 and the partner datacenter router 138 via the private dedicated network. The partner datacenter router 138 is located behind a firewall 130 to provide securityfrom unauthorized interne access. And, as discussed above, use of aprivate dedicated network to facilitate the transmission of data whenthe partner server 132 is provided at a location remote from thelocation of the partner workstations 112 causes those components toperform like a private dedicated network and provides additionalsecurity to that network. Although the exemplary embodiment illustratedin FIG. 1 utilizes a broadband network when the partner server 110 isprovided at the researcher's site 108 and a private dedicated networkwhen the partner server 132 is provided at the partner data center 134,either a broadband network or a private dedicated network may beutilized in either configuration.

The enhanced services server 116 of the IPI provider system contains allof the system applications used by the IPI provider to control andmaintain the operation of the various systems of the IPI 100. Theenhanced services server 116 also controls communications with systemsoutside of the IPI 100 and stores data aggregated from the varioussystems of the IPI 100. The enhanced services server 116 is provided atthe center of the IPI 100 and can therefore serve as a centralizedrepository for the data aggregated from the various systems of the IPI100. Access to that repository of data is controlled by the enhancedservices server 116.

The administrator workstation 118 provides a point of communicationbetween IPI administrators and the enhanced services server 116 andother systems within the IPI 100. The administrator workstation 118 maybe provided at a location remote from the enhanced services server 116at the IPI provider's site 114. The administrator workstation 118communicates with the enhanced services server 116 over a LAN via aprovider router 126. The enhanced services server 116 and administratorworkstation 118 also communicate with the client servers 104 and clientworkstations 106 of the EHR systems and the partner servers 110 andpartner workstations 112 of the research systems via the providerrouters 126 provided at the IPI provider's site 114. As discussed above,the provider routers 126 communicate with the client routers 124, theclient data center routers 128, the partner routers 136, and the partnerdata center routers 138 of the EHR systems and research systems,respectively, via a broadband network and/or a private dedicatednetwork. The enhanced services server 116 can control at least oneinternet router 140 that is used to provide the various systems of theIPI 100 access to the internet when the client server 104 or partnerserver 110 do not provide such access. The internet router 140 islocated behind a firewall 130 to provide security from unauthorizedinternet access. Administrative functionality for the applications ofeach system in the IPI 100 can be handled through the administratorworkstation 118.

The functionality provided at each workstation 106, 112, and 118 isimplemented via a single technology platform, such as web technologiesthat include markup languages, programming interfaces and languages, andstandards for document identification and display (e.g., HyperTextMarkup Language (HTML), Visual Basic Script (VBScript), ExtensibleMarkup Language (XML), Scalable Vector Graphics (SVG), JAVASCRIPT brandlanguage, Cascading Style Sheets (CSS), Document Object Model (DOM),Virtual Reality Modeling Language (VRML), UNIX brand language, etc.).Those web technologies are utilized to provide users of the systems ofthe IPI 100 with web-browser-type user interfaces for communicating withthe systems of the IPI 100. Accordingly, those web technologies may beused to facilitate remote access to all of the applications and datamaintained by the various servers 104, 110, and 116 of the IPI 100within a highly secured environment and enable communication betweenclients, partners, and administrators. Thus, substantially any devicecapable of employing those web technologies can be utilized as aworkstation 106, 112, and 118 (e.g., a personal computer (PC), a laptop,a Personal Digital Assistant (PDA), a Secure Mobile Environment PortableElectronic Device (SME PED), etc.).

The functionality of each server 104, 110, 116, 120, and 132 of the IPI100 is implemented via a central processor that manages the launching ofscript files and controls the operation of each server. Each centralprocessor utilizes a central service utility that runs in the backgroundand automates tasks within each system and across all of the systems ofthe IPI 100. Thus, the central service utility includes two types ofutilities, one that runs on the individual servers 104, 110, 116, 120,and 132 of the respective systems and one that runs across all of theservers 104, 110, 116, 120, and 132 of the IPI 100.

The central service utility utilizes an event-driven design to performtasks by monitoring a set of directories on the various servers 104,110, 116, 120, and 132 of the IPI 100 and identifying the presence of anevent or flag file before initiating, or triggering, an associatedscript or application. Multiple scripts and flags can be used togetherto complete tasks, and each task may consist of multiple scripts and/orthird party programs. An event may include an empty file, a filecomprising a single line of data, or a complete data file; and a flagfile contains data that indicates what task is to be performed based onthe event.

The central service utility supports tasks performed by standardinternet-based services (e.g., Internet Information Services (IIS) andActive Server Page Network (ASP.NET) services) and standardsoftware-framework-based services (e.g., Component Object Model Plus(COM+) and .NET services). The internet-based services providefunctionality for the robust, interactive data exchange processes of thepresent invention, and provide functionality for presenting data tousers of the various systems of the IPI 100 in a web-browser-typeformat. The software-framework-based services provide functionality forcentrally managing all of the business logic and routines utilized bythe present invention.

Each of the servers 104, 110, 116, 120, and 132 of the IPI 100 alsoinclude functionality for managing a relational database. Each databaseutilizes relational technology (e.g., a Relational Database ManagementSystem (RDBMS)) to manage all discrete data centrally, which facilitatesthe seamless sharing of information across all applications within eachsystem of the IPI 100. And, by using standardized medical vocabulariesto normalize data within each system of the IPI 100, information canalso be shared seamlessly across the various systems of the IPI 100.That functionality reduces the potential for redundant data entry anddata storage at the client server 104, 120 and partner server 110, 132as that data is captured, and at the provider server 116 as that data isaggregated from the other servers. In addition, by storing data inrelational databases, that data can be more efficiently queried toproduce de-identified data sets.

To further facilitate the efficient querying of data, each database alsoutilizes standardized database languages designed for the retrieval andmanagement of data in relational database, such as the Structured QueryLanguage (SQL) and XML-Related Specifications (e.g., SQL/XML). Thosestandardized database languages are used to assign normalized extensionsto particular types of data so that data can be more easily locatedwithin a database. And, in addition to standard extensions provided aspart of those languages, those languages can also be used to defineproprietary extensions unique to the system in which they are employed.Accordingly, the present invention provides functionality for storingdata in a meaningful way that provides fast, easy access by any systemin the IPI 100, which further enhances the data querying capabilities ofthe present invention.

In a preferred embodiment, the functionality provided at eachworkstation 106, 112, and 118 and each server 104, 110, 116, 120, and132 of the IPI 100 is implemented using a tiered architecture. Forexample, the functionality of the workstations 106, 112, and 118 may beimplemented in a user tier; the functionality of the central serviceutility of the servers 104, 110, 116, 120, and 132 may be implemented ina business tier; and the functionality of the databases of the servers104, 110, 116, 120, and 132 may be implemented in a data tier.Accordingly, both a data tier and a business tier are located on eachserver 104, 110, 116, 120, and 132, while a client tier is located oneach workstation 106, 112, and 118. In that configuration, the businesstier is the middle tier and utilizes its standard internet-basedservices and standard software-framework-based services to analyze,collect, and track the data in the data tier and present it to a user ofthe IPI 100 at the user tier. The business tier may access the data inthe data tier using a set of computer software components provided aspart of the software-framework-based services (e.g., ADO.NET), and maytransmit that data to the client tier using application-level protocolfor the internet-based services (e.g., Hypertext Transfer ProtocolSecure (HTTPS)).

That architecture may be based on Microsoft Corporation's DistributedInternet Applications (DNA) architecture, which uses .NET objects andWeb Services for business rules and COM+ for resilient database storageand retrieval. Using the DNA architecture, the user tier would utilizeMicrosoft Corporation's Smart Client software as the client platform;the business tier would be implemented on Microsoft Corporations WINDOWS2008 brand server using IIS, ASP.NET, Microsoft Corporation's ComponentService, and .NET middle-tier objects; and the data tier would implementMicrosoft Corporation's SQL*Server. Such a standard n-tier design modelprovides separation of the detailed business rules from the data storagefunctionality at the data tier and data presentation functionality atthe user tier. In the present invention, such architecture also providesfor tighter integration of the functionality within each system of theIPI 100.

In addition, the integrated architecture of the present inventionenables a single source of support to minimize the cost of ongoingsystem maintenance and provides a scalable solution that allows thevarious systems of the IPI 100 to be expanded or contracted for largehealthcare communities or specific healthcare specialties, respectively.Moreover, providing a single-vendor solution on a single technologyplatform in that manner allows the IPI provider to push new or updatedsystem software to all of the systems in the IPI 100 simultaneouslywhenever that software is replaced or revised, thus ensuring seamlessdata exchange across all of those systems.

To further facilitate the seamless exchange of data across all of thosesystems, each of the various systems of the IPI 100 may utilize acontrolled medical vocabulary, such as the Systematized Nomenclature ofMedicine, Clinical Terms (SNOMED CT). SNOMED CT is a scientificallyvalidated collection of well-formed, machine-readable, and multi-lingualhealthcare terminology that provides a standardized nomenclature for usein capturing, indexing, sharing, and aggregating healthcare data acrossspecialties and sites of care. Because the common language employed bySNOMED CT reduces the variability in the way data is captured, encoded,and used, it is particularly suited for use in electronic medicalrecords, ICU monitoring, clinical decision support, medical researchstudies, clinical trials, computerized physician order entry, diseasesurveillance, image indexing, and consumer health information services.SNOMED CT is currently maintained by the International HealthTerminology Standards Development Organization (IHTSDO).

The present invention also utilizes other standardized medicalterminologies and classification systems, such as the InternationalClassification of Diseases (ICD), RxNorm, Logical ObservationIdentifiers Names and Codes (LOINC), and Current Procedural Terminology(CPT). ICD is a coded classification system for identifying the signs,symptoms, abnormal findings, complaints, social circumstances, andexternal causes of various injuries and diseases, and it is currentlymaintained jointly by the National Center for Health Statistics (NCHS)and the Centers for Medicare & Medicaid Services (CMS). RxNorm is acoded classification system for identifying clinical drugs and dosesadministered to patients, and it is currently maintained by the NationalLibrary of Medicine (NLM). LOINC is a coded classification system foridentifying laboratory and clinical observations, and it is currentlymaintained by the Regenstrief Institute, Inc. And, CPT is a codedclassification system for describing medical, surgical, and diagnosticprocedures, and it is currently maintained by the American MedicalAssociation (AMA). By using those standardized nomenclatures, thepresent invention avoids duplicate data capture while facilitatingenhanced health reporting, billing, and statistical analysis. And, bymapping each of those standardized nomenclatures to the SNOMED CTvocabulary, duplicate data capture is further avoided while providing aframework for managing different language dialects, clinically relevantsubsets, qualifiers and extensions, as well as concepts and terms uniqueto particular organizations or localities.

The present invention maintains each of those standardized nomenclaturesacross all of the systems of the IPI 100 in an extensive “back-end”repository so that they can not only be mapped to data captured by thosesystems, but can also be mapped to other widely accepted codedclassification systems to further improve the functionality of thepresent invention. For example, ICD codes can be mapped to associatedCPT codes for claims processing, CPT codes can be mapped to result codesfrom various laboratories to facilitate lab interactions, and RxNormcodes can be mapped to First DataBank, Inc.'s NATIONAL DRUG DATA FILEPLUS (NDDF PLUS) brand coded classification system to facilitatepharmacy management and drug interaction analysis. In addition tonormalizing data throughout the IPI 100 to eliminate duplicate datacapture and to streamline the sharing of data, the use of all of thestandardized nomenclatures described herein also allows the varioussystems of the IPI 100 to more easily mediate inbound and outbound datacommunications with external information systems 142 outside of the IPI100. External information systems 142 include, but are not limited to,external EHR systems, external research systems, disease registrysystems, public health organization systems, safety/quality organizationsystems, and claims processing systems.

When the systems of the IPI 100 must interface with external informationsystems 142 to facilitate the exchange of data in real time, the presentinvention includes an interoperability engine to facilitate integrationwith such external information systems 142. The interoperability enginesupports various standardized formats as well as various vendor-specificdelimited files and fixed width files. Thus, instead of relying ondistributed interfaces to various applications, the present inventionprovides a single platform maintained on the secure, managed networkinfrastructure of the IPI 100, thereby extending the seamless exchangeof data across the various systems of the IPI 100 to include externalinformation systems 142.

For example, the interoperability engine supports a uniform messagingstandard, such as the Health Level Seven (HL7) messaging standard, foridentifying triggering events and the associated data that is to beexchanged based on the triggering event. In the present invention, atriggering event includes an event at a client's site 102 or a partner'ssite 108 that creates the need for data to flow among systems, such asregistering a new patient at a client's site 102 or submitting availableclinical trials at a partner's site 108. Among the external informationsystems 142 that can be interfaced in real time using the HL7 messagingstandard are EHR systems that include diagnostic equipment for capturingdata at the point of care. Accordingly, the systems of the IPI 100 canexchange information such as patient demographics, processingpre-certifications, orders, results, labs, and prescriptions withexternal information systems 142 in real time based on triggeringevents. The HL7 messaging standard is utilized by most healthcareinformation systems, such as the hospital information systems providedby McKesson HBOC Inc., Meditech Inc., and Cerner Corp. The contents ofthe HL7 messaging standard are hereby incorporated by reference.

In addition to supporting a uniform messaging standard for the real-timeexchange of data with external information systems 142, theinteroperability engine of the present invention also supports a uniformdocument standard, such as the Continuity of Care Document (CCD)standard, for specifying the structure and semantics of electronicdocuments in which data is captured. The CCD standard is a structuredExtensible Markup Language (XML) standard developed by HL7 and theAmerican Society for Testing and Materials (ASTM) to harmonize the dataformat between HL7's Clinical Document Architecture (CDA) standard andASTM's Continuity of Care Record (CCR) standard. The CDA standardprovides an exchange model for clinical documents (e.g., dischargesummaries and progress notes) that uses various coded vocabularies(i.e., the coded vocabularies discussed above, such as ICD, etc.) toassign both computer-readable structured components and human-readabletextual components to electronic documents so those documents can beeasily parsed and processed electronically and retrieved, read, andunderstood by the people who use them. And, the CCR standard providespatient health summary model for clinical documents by identifying themost relevant and timely core health-related information about a patientso that information can be sent electronically from one healthcareprovider to another. Thus, the CCD adds content to the exchange model ofthe CDA by using the summary model of the CCR to identify the varioussections of the clinical document that collectively represent a“snapshot” of a patient's information, such as the patient'sdemographics, insurance information, diagnosis, problem list,medications, allergies, and care plan. Accordingly, the CCD standardsupports more streamlined exchanges with and between EHR systems thansupported by the CDA and CCR standards alone. The contents of the CCDstandard are hereby incorporated by reference.

Supported by the CCD document standard, the interoperability engine ofthe present invention also supports a uniform form management standard,such as the Retrieve Form for Data Capture (RFD) form managementstandard, to facilitate the retrieval, completion, and submission offorms between the systems of the IPI 100 and with external informationsystems 142. The RFD standard was developed through a joint effortbetween the Integrating the Healthcare Enterprise (IHE) and ClinicalData Interchange Standards Consortium (CDISC) organizations to advancepublic health by providing a standardized means for retrieving andsubmitting forms data between researchers and healthcare providers andelectronic data capture systems and other data collection agencies. TheRFD standard makes medical research and healthcare more efficient byproviding a method for capturing data within a user's currentapplication in a manner that meets the requirements of an externalsystem. The RFD standard supports the retrieval of forms from a FormManager, display and completion of a form by a Form Filler, and returnof instance data from the display application to a Form Receiver and aForm Archiver.

A Form Manager is responsible for providing the desired form, such asthe Food and Drug Administration (FDA). A Form Filler is responsible forinputting data into the form, such as the user of an EHR system. A FormReceiver is responsible for receiving the primary data input by the FormFiller for processing purposes. And, a Form Archiver is responsible forreceiving the data input from the Form Filler for archival purposes. TheForm Receiver and Form Archiver may or may not be the same entity aseach other, the Form Manager, or the Form Filler. The contents of theRFD standard are hereby incorporated by reference.

In addition to facilitating integration with external informationsystems 142, the CCD document standard and RFD form management standardcan also be utilized within each system of the IPI 100 to facilitate theseamless exchange of data between those internal systems. Thus, thepresent invention provides a computer-based production environment thatutilizes the CCD document standard and RFD form management standard tocollect patient information in real time at the point of care using aplurality of EHR systems, both those that are part of the IPI 100 andthose that are external to the IPI 100. Moreover, by facilitating theintegration of external information systems 142 with the systems of theIPI 100 using the standardized formats supported by the interoperabilityengine, the present invention provides functionality for a researcher tocollect medical data across an even larger patient population than thatcovered by various systems of the IPI 100.

In addition, utilizing those standardized medical terminologies andclassification systems facilitates both systematic and data-levelintegration across each of the systems of the IPI 100 such that theresearch functionality of the research systems is seamlessly integratedinto the workflows of the EHR systems, which eliminates duplicate dataentries between the EHR systems and the electronic source documentationof the research systems. And, because the IPI 100 of the presentinvention includes a network of EHR systems that are built on the samearchitecture as the research systems, that research functionality can beemployed seamlessly across the entire IPI 100 to simultaneously collectdata from all of the EHR systems and electronically transfer thecollected data to the research systems, which benefits all stakeholdersby decreasing the input time and increasing the accuracy of data.Moreover, by providing an interoperability engine that integrates thosesystems with external information systems 142, the researchfunctionality of the present invention can also be employed seamlesslyacross external research systems 142 to exchange data with external EHRsystems and external research systems. Accordingly, that data can easilybe exchanged with data from other clinicians, research institutes,universities, and pharmaceutical companies for broad-based ongoingresearch and can be used by researchers, scientists, and physicians tobetter understand and combat health issues and diseases.

Each system of the IPI 100 also includes features that address all ofthe security, privacy, and transactional regulations of the HealthInsurance Portability and Accountability Act (HIPAA). To address HIPAA'ssecurity regulations, each system of the IPI 100 may include biometriclogin; restricted access based on login authorization (e.g., restrictingaccess to only individual charts or chart sections); routine andevent-based audits to identify potential security violations (e.g.,identify who looked at what section of a chart and when); and restrictedability to copy, print, fax, e-mail, and export information based onlogin authority. To address HIPAA's privacy regulations, each system ofthe IPI 100 may include functionality for consent tracking anddisclosure logging, functionality for de-identifying data, andfunctionality for automatically populating consent forms with theextensive details required by HIPAA explaining how a participant'sprotected information will be kept private. And, to address HIPAA'stransactional regulations, each system of the IPI 100 may utilizeElectronic Data Interchange (EDI) standards to structure the electronictransfer of claim billing information between the systems of the IPI 100and external information systems 142, such as a claims processingsystem. The contents of HIPAA are hereby incorporated by reference.

By providing automated compliance with many of the requirements ofHIPAA, the present invention helps resolve many of the intricacies ofHIPAA, which alleviates much of the concern healthcare providers havehad with the complex legalities and potentially stiff penaltiesassociated with HIPAA. In addition, by providing a system thatstreamlines and automates the electronic capture and flow of databetween healthcare providers in a secured manner, the present inventionalso eliminates much of the additional paperwork and labor associatedwith HIPAA, which reduces the amount of cost, time, and physical spacerequired of healthcare providers to comply with HIPAA. And, by providinga single-vendor IPI 100 comprising a large number of integrated EHRsystems and research systems, the present invention provides access todata for a vast patient population that can be used in clinical trials,disease registries, evidence-based medical and pharmaceutical research,and clinical and financial statistical analysis. Accordingly, thepresent invention makes it easier for researchers to recruit patientsfor research by reducing the time and costs associated with recruitingthose patients, which not only overcomes many of the research relatedproblems associated with existing paper-based processes and theregulations of HIPAA, but also provides a mechanism for healthcareproviders to increase revenue and foster the ongoing improvement inquality of care for patients through their participation in the researchfacilitated by the present invention.

By way of further non-limiting example, the research functionality ofthe present invention may be used to quickly and accurately locate alarge number of patients for participating in a clinical trial byrunning a sequential filtering process across the systems of the IPI100. By utilizing an IPI 100 that includes a large network of EHRsystems built on the same architecture, the filtering process can be runquickly and accurately across the databases on each client server 106and/or querying a central database on the enhanced services server 116.And, where the IPI 100 is employed on a national scale, the results ofthat filtering process provide a larger pool of patients, and thereforea more desirable cross-section of people, from which researchers canrecruit participants for clinical trials. For example, utilizing thepresent invention over Greenway Medical Technologies, Inc.'s IPI willcurrently provide researchers access to data for more than fourteenmillion active patients collected at more than eight hundred sixtyhealthcare provider sites across at least forty-seven U.S. states.Collecting, tracking, and analyzing data on such an expansive scale isindicative of the present invention's functionality.

Thus, a clinical trial sponsor, such as a pharmaceutical company, canutilize the present invention to quickly and accurately identify andregister patients that qualify for clinical trials. The clinical trialsponsor can become a partner with the IPI provider and utilize thefunctionality of the present invention to locate patients within the IPI100 network that qualify for a clinical trial, or the clinical trialsponsor can solicit proposed clinical trials through Clinical ResearchOrganizations (CROs) who will become partners of the IPI provider andutilize the functionality of the present invention to locate patientswithin the IPI 100 network that qualify for a proposed clinical trial.To utilize that functionality, the clinical trial sponsor or CRO willdevelop specific clinical criteria that patients must satisfy to qualifyfor participation in the clinical trial. Those criteria are given to theIPI provider, who utilizes the present invention to run a sequentialfiltering process 300 and determine the number of patients within thenetwork of the IPI 100 that qualify for the clinical trial. In thealternative, the clinical trial sponsor or CRO may utilize the presentinvention to run the sequential filtering process. But, before aclinical trial sponsor or CRO obtains access to the network of the IPI100 and/or the data captured thereon, the clinical trial sponsor or CROmust register as a research partner of the IPI provider and agree tocertain provisions to ensure compliance with HIPAA's regulations.

As FIG. 2 illustrates, the partner registration process 200 includesseveral steps before a potential research partner can utilize thefunctionality of the present invention. At step 202 of the partnerregistration process 200, a potential research partner can contact theIPI provider or the IPI provider can contact the potential researchpartner via any suitable means, such as via a link on the IPI provider'sinternet home page or via an e-mail. At step 204 of the partnerregistration process 200, the IPI provider and the potential researchpartner explore the possibility of the partnership and determine whetherthe two entities are compatible with each other for performing thedesired research. If the IPI provider and the potential research partneragree that they are compatible, the IPI provider sends a PartnerResearch Agreement to the potential research partner at step 206 of thepartner registration process 200.

The IPI provider and the potential research partner may negotiate theterms of the Partner Research Agreement, except for those requiringcompliance with the regulations of HIPAA and other state and federallaws. For example, the IPI provider and the potential research partnermay negotiate the format and protocol by which data will be exchangedbetween the potential research partner's research system and externalinformation systems 142 utilized by the potential research partner, suchas a Clinical Trials Management Systems (CTMS) and/or Electronic DataCapture (EDC) systems. The Partner Research Agreement may also identifya CRO, such as eCast Corp. or Outcome Sciences Inc., who will provide aClinical Research Coordinator (CRC) to conduct the clinical trial at thepoint of care. After all of the terms of the Partner Research Agreementare negotiated, the agreement is executed and returned to the IPIprovider at step 208 of the partner registration process 200.

If the research partner negotiated for its research system to bedeveloped to exchange data with any of the research partner's externalinformation systems 142 in a format other than the standardized formatin which that data is captured by the systems of the IPI 100, theinteroperability engine is used to facilitate integration of thoseexternal information systems 142 with the research partner's researchsystem at step 210 of the partner registration process 200. Afterintegration development is completed at step 212 of the partnerregistration process 200, or if no integration was required, thepartner's research system is added to the network of the IPI 100 at step214 of the partner registration process 200. After the researchpartner's research system is added to the network of the IPI 100, theresearch partner is given access to a research partner web portal atstep 216 of the partner registration process 200 through which theresearch partner can manage its research system, set up data feeds, andrun queries. Managing its research system includes viewing thoseresearch tasks the research partner is in charge of completing, andsetting up data feeds and running queries includes choosing the criteriaby which de-identified data is collected, tracked, and analyzed by theresearch system.

As FIG. 3 illustrates, the research system may analyze, collect, and/ortrack data by applying a sequential filtering process 300 to generatede-identified data sets from the data captured by the various systems ofthe IPI 100. The sequential filtering process is performed by a codifiedsearch of a universal vocabulary common to all databases using the SQLlanguage to compare lexicons and prepare the desired result. That searchcan be performed utilizing functions/procedures that can be integratedinto the databases of the various systems of the IPI 100. Such functionsinclude SQL functions and, for large and/or complex queries, StoredProcedures (SPs) and User Defined Functions (UDFs). Using thosefunctions, data can be efficiently queried from the databases of thevarious servers 104, 110, 116, 120, and 132 of the IPI 100, eitherindividually, simultaneously, or at a central database where data hasbeen aggregated (e.g., the database on the enhanced services server116).

In the example illustrated, the sequential filtering process includessteps 302-308 for determining the number of patients among a large poolof patients that qualify for a clinical trial 310 (hereinafter“qualifying patients 310”). Although FIG. 3 illustrates separate stepsfor performing the sequential filtering process, the researchfunctionality of the present invention automatically performs thoseafter a research partner chooses the criteria by which qualifyingpatients 310 are to be identified. According, a research partner needmerely choose the criteria for identifying patients that qualify for aclinical trial via its research partner web portal, and the researchfunctionality will automatically perform the sequential filteringprocess across the systems of the IPI 100 to determine the number ofpatients that satisfy all of those criteria.

In addition, although the pool of patients illustrated in FIG. 3 onlyincludes twenty-four patients, that number of patients is provided forease of explanation. As discussed above, the pool of patients canactually include fourteen million or more active patients. Among thepool of patients at each step, there may be patients that do not satisfythe associated criteria 312 and patients that do satisfy the associatedcriteria 314 in addition to the qualifying patients 310 that qualify forthe clinical trial by satisfying the criteria at every step.

Step 302 in the exemplary sequential filtering process 300 includesquerying de-identified patient diagnosis/medical history data anddetermining the number of patients with specific diagnoses. Thosediagnoses are queried based on the ICD values captured for thosepatients (e.g.; V78.1, which corresponds to screening for other andunspecified deficiency anemia; 280.0, which corresponds to irondeficiency anemia secondary to blood loss (chronic); 280.9, whichcorresponds to iron deficiency anemia unspecified; and 285.1, whichcorresponds to acute posthemorrhagic anemia). Step 302 in the sequentialfiltering process 300 reveals that twenty of twenty-four patients havebeen diagnosed with at least one of the health conditions specified.

Step 304 in the exemplary sequential filtering process 300 includesquerying de-identified patient lab results data and determining thenumber of the remaining twenty patients that have a mean corpuscularvolume (MCV) less than eighty, low hemoglobin (HgB), or low serum iron.The patient lab results may be queried based on the associated LOINCclassification. Because the filtering process is sequential, only thedata for the twenty patients that satisfied the criteria at step 302 arequeried at step 304. Step 304 in the sequential filtering process 300reveals that sixteen of the twenty patients that have been diagnosedwith at least one of the health conditions specified in step 302 alsohave the lab results specified in step 304.

Step 306 in the exemplary sequential filtering process 300 includesquerying de-identified patient demographic data and determining thenumber of the remaining sixteen patients that are eighteen years old orolder. The demographic data is de-identified in accordance with theHIPAA privacy regulations, so the only element of data that is queriedis the year. Again, because the filtering process is sequential, onlythe sixteen patients that satisfied the criteria at step 302 and step304 are queried at step 306. Step 306 in the sequential filteringprocess 300 reveals that twelve of the sixteen patients that have beendiagnosed with at least one of the health conditions specified in step302 and at least one of the lab results specified in step 304 alsosatisfy the demographic requirement specified in step 306.

Step 308 in the exemplary sequential filtering process 300 includesquerying de-identified patient medication data and determining thenumber of the remaining twelve patients that have been prescribed eitherMetformin or GLUCOPHAGE brand Metformin The patient medication data maybe queried based on its associated RxNorm classification. By queryingonly the twelve patients that satisfied the criteria at steps 302-306,step 308 in the sequential filtering process 300 reveals that four ofthe original twenty-four patients have been diagnosed with at least oneof the health conditions specified in step 302, have at least one of thelab results specified in step 304, satisfy the demographic requirementspecified in step 306, and have been prescribed one of the medicationsspecified in step 308. Thus, the sequential filtering process 300determines that there are four qualifying patients 310 that qualify forthe clinical trial by satisfying each of the established criteria.

At step 316, any additional de-identified data that is relevant to theclinical trial is retrieved from the IPI 100 for qualifying patients310. And, at step 318, all of the retrieved data for the qualifyingpatients 310 is presented in the form of an electronic report or adataset. When the sequential filtering process 300 is initiated by theIPI provider at the IPI provider's site 114, the electronic report ordataset is presented to the IPI provider at an administrator workstation118 and can be transferred to the research partner that requested it ata researcher's site 108 or a third party (e.g., a pharmaceuticalcompany) at an external information system 138 via one of the securedconnections of the IPI 100. And, when the sequential filtering process300 is initiated by a research partner at the researcher's site 108 oris transferred from the IPI provider to the research partner at theresearcher's site 108, the electronic report or dataset is presented tothe research partner at a partner workstation 112. A research partnercan transfer the electronic report or dataset from the researchpartner's research system to an external information system 142, such asa CTMS or EDC system, via one of the secured connections of the IPI 100.Regardless of who initiates the sequential filtering process via theresearch system, the research partner can establish the criteria forthat search through its research partner web portal using its partnerworkstation 112, which, as discussed above, may include a PC, a laptop,a PDA, and an SME PED.

Thus, the present invention can utilize a sequential filtering process300 to quickly and accurately generate an electronic report or datasetfor patients that qualify for a clinical trial that can be easilydisseminated to the parties requesting that data. Moreover, that datacan be collected in a matter of minutes in lieu of the months it used totake to identify qualifying patients 310, which saves clinical trialsponsors and CROs millions of dollars. And, because the presentinvention provides an integrated system comprising standardized data forover fourteen million active patients, the patients that qualify for theclinical trial represent a more accurate cross-section of the populationfrom which they are drawn, which is extremely desirable for clinicaltrials.

Although the sequential filtering process 300 illustrated in FIG. 3 isdescribed with respect to locating patients that qualify for clinicaltrials, the present invention also provides similar researchfunctionality for generating reports or datasets of other clinical andfinancial information across the vast network of the IPI 100. Forexample, the present invention can be used to analyze, collect, andtrack data for comparing a medical practice to other practices (e.g., inthe same specialty, in the same region, of the same size, etc.) based oncustomized criteria (e.g., previous performance, specified financialgoals, etc.) or national standards and benchmarks (e.g., Medical GroupManagement Association (MGMA) certifications, Agency for HealthcareResearch and Quality (AHRQ) quality indicators, National Committee forQuality Assurance (NCQA) accreditations, Healthcare Effectiveness Dataand Information Set (HEDIS) measures, CMS initiatives, etc.). Thepresent invention performs analytics on those electronic reports ordatasets to generate average values that can be easily compared byclients and research partners. Such comparisons provide healthcareproviders with guidance for improving the clinical quality and financialperformance of their respective practices.

The present invention also provides functionality similar to thesequential filtering process 300 illustrated in FIG. 3 for generatingreports or datasets that track the effects of various drugs and medicalprocedures on patients within the network of the IPI 100. For example, aresearch partner, such as a pharmaceutical company, can utilize thepresent invention to identify any adverse effects of one of its drugs bytracking patients that have taken that drug, alone or in combinationwith other drugs, and determining whether any pattern of illnesses orside effects appears among those patients. And, because the IPI 100 ofthe present invention actively analyzes, collects, and tracks data inreal time, drug companies can quickly and accurately identify anyadverse events and respond by removing the drug from the market oraltering the composition of the drug. Moreover, the present inventionprovides functionality that allows the IPI provider or a researchpartner to establish criteria for automatically identifying such adverseevents as they occur.

In addition to tracking adverse events, the research functionality ofthe present invention can also be used to track the efficacy of variousdrugs by tracking actual usage of those drugs in various scenarios. Thatdata can be used to verify and reinforce the conclusions drawn as aresult of a clinical trial and confirm that marketing authorization ofthe drug was valid. Accordingly, the research functionality of thepresent invention can be utilized to accomplish any requiredpharmacovigilance (PV) activities during a drug's post-marketing period,such as those required by the World Health Organization (WHO)International Drug Monitoring Programme. For example, the presentinvention can be used to study how certain drugs are used and theirimpact on pregnancy outcomes by identifying pregnancy events across thesystems of the IPI 100 and linking them to child births and deaths,birth defects, and the drugs administered to the pregnant patients basedon the data captured for the pregnant patients at the various systems inthe IPI 100.

The research functionality of the present invention can also be used toprovide real-time feedback for various other purposes, such as trackingdiseases for disease registries or even tracking the flu. Moreover, thattype of data tracking can be performed by globally polling the data onthe systems of the IPI 100 as a whole in lieu of querying that data toidentify specific datasets. Utilizing that broader, global pollingfunctionality in real time, the research functionality of the presentinvention can be used as an electronic biosurvielance system forproviding early warnings of health threats, early detection of healthevents, and overall situational awareness of disease activity on anational scale. The research functionality achieves those objectives bymonitoring the environment for bacteria, viruses, and other biologicalagents that cause disease in real time across all of the systems of theIPI 100.

Returning to the example of the present invention's functionality foridentifying qualifying patients 310, the sequential filtering process300 only identifies the number of patients that satisfy all of thecriteria for a clinical trial and provides de-identified data for thosepatients. The query results do not include any patient-specificinformation. For a research partner to obtain access to patient-specificdata from a particular user of the IPI 100, that user must establish aformal relationship with the IPI provider by becoming a research clientof the IPI provider. Accordingly, the present invention also providesfunctionality for recruiting IPI users to become research clients of theIPI provider. When an IPI user becomes a research client of the IPIprovider, the IPI user not only authorizes research partners of the IPIprovider to access patient-specific data for the IPI user's patientpopulation, the IPI user is also given access to the infrastructurewithin the IPI 100 that interconnects all of the systems of the IPI 100to the IPI provider's research partners' research systems (hereinafter“the Research Network”).

As FIG. 4 illustrates, the client registration process 400 includesseveral steps before an IPI user can access the Research Network of thepresent invention. At step 402 of the client registration process 400, apotential user of the IPI 100 may contact the IPI provider to become ageneral client of the IPI provider and obtain at least one of theservices provided by the IPI provider (e.g., an EHR system). In thealternative, the IPI provider may solicit potential IPI users to obtainat least one of the services provided by the IPI provider or may contactexisting general clients that have already obtained at least one of theservices provided by the IPI provider. Once contact is made at step 402of the client registration process, the potential IPI user or existinggeneral client is asked if it would like to be a research client inaddition to being a general client at step 404 of the registrationclients. By becoming a research client in addition to a general client,an IPI user is able to participate in the Research Network of thepresent invention as part of the services provided to the user by theIPI provider. Accordingly, the present invention provides an effectivemeans for recruiting healthcare providers to participate in its ResearchNetwork.

If the IPI user is interested in participating in the Research Network,a Client Research Agreement is sent to the IPI user at step 406 of theclient registration process 400 via any suitable means, such as viae-mail or via a link in the web portal of the system the IPI user isutilizing to obtain the IPI provider's services. The terms of thatagreement set out the requirements that will be adhered to by bothparties to ensure compliance with the regulations of HIPAA and otherstate and federal laws. If the IPI user agrees to the terms of theClient Research Agreement, the agreement is executed and returned to theIPI provider at step 408 of the client registration process 400. Becausethe IPI user is already using the services of the IPI provider, thesystem that the IPI user is utilizing to obtain those services isalready integrated into the network of the IPI 100, and no integrationis required for the IPI user to become part of the Research Network.

After the IPI user has executed and returned the Client ResearchAgreement at step 408 of the client registration process 400, theresearch client is given access to the Research Network at step 410 ofthe client registration process 400. The research client can access theResearch Network at step 412 of the client registration process 400 viaa research client web portal. The research client web portal providesfunctionality for the research client to easily view all of the clinicaltrials for which any of its patient's qualify, the criteria for each ofthose trials, and all of the patients that qualify for those trials. Theresearch client can configure the research client web portal to sendautomatic notifications of any new clinical trials for which itspatients qualify. The research client can also request to opt in to anyavailable clinical trial via the research client web portal.

Participation in a clinical trial can be a source of income for thoseresearch clients that opt in to such trials, which serves as anincentive for more IPI users to become research clients. The more IPIusers that become part of the Research System, the more powerful of aresearch tool the Research System becomes. But, before a research clientcan begin participating in a clinical trial, the qualifying patients 310may need to be screened and give their authorization to verify theireligibility for the clinical trial.

As FIG. 5 illustrates, the patient verification process 500 includesseveral steps before the research client becomes active in a clinicaltrial. At step 502 of the patient verification process 500, a researchclient can query or receive a notification from the Research Network ofthe available clinical trials for which the research client qualifies.Or, in the alternative, the research partner may query or receive anotification from the Research Network at step 502 of the patientverification process, identifying which research clients qualify forthat research partner's clinical trial. Based on that query ornotification, the research partner may contact the qualifying researchclient or the service IPI provider at step 504 of the verificationprocess 500 to request that the qualifying research client participatein the research partner's clinical trial. Or, in yet anotheralternative, the IPI provider may automatically request that thequalifying research client participate in the research partner'sclinical trial at step 504 of the verification process 500 based on itsown query of the Research Network. Regardless of who generates therequest for the qualifying research client to participate in theresearch partner's clinical trial, that request will go through the IPIprovider so the IPI provider can facilitate verification of thequalifying patients 310 and execution of a Partner-Client Agreementbetween the research client and the research partner before the researchclient begins participating in the clinical trial via the IPI 100.

At step 506 of the verification process 500, the qualifying researchclient can opt in to the research partner's clinical trial based on theresearch client's query or notification at step 502 or based on the IPIprovider's or research partner's request at step 504. After opting in tothe clinical trial, the research client must verify its population ofqualifying patients 310 at step 508 of the verification process 500.Verifying that a research client's qualifying patients 310 are eligiblefor the clinical trial may include a screening process by which theresearch client schedules follow-up visits (e.g., preemptoryevaluations) with its qualifying patients 310 to run any other necessarytests to ensure that the qualifying patients 310 satisfy the requisitecriteria for the clinical trial. Verifying that a research client'squalifying patients 310 are eligible for the clinical trial may alsoinclude having the qualifying patients 310 sign a consent form,pre-populated with the required HIPAA-mandated language regarding thepatients' protected information, authorizing their physician to placeeach patient's information on the Research Network.

If a research client's qualifying patients 310 are verified as eligibleto participate in the research partner's clinical trial at step 510 ofthe verification process 500, the IPI provider sends the research clientand research partner a Partner-Client Agreement at step 508 of theverification process 500. The Partner-Client Agreement is between theresearch client and the research partner and sets forth all of therequirements and payments associated with performing the clinical trial.The Partner-Client Agreement also includes all language required toensure both parties comply with the regulations of HIPAA. After bothparties have executed the Partner-Client Agreement and returned it tothe IPI provider at step 514 of the verification process 500, theresearch functionality of the present invention is deployed to theresearch partner and research client so they may go live and begincapturing clinical data in real time at the system of the IPI 100utilized by the research client (e.g., an EHR systems).

As part of the research functionality deployed, the verified patientsthat are participating in the clinical trial are attached to thespecific clinical trial so that the proper forms required for thatclinical trial are automatically associated with and made available forthose patients. In addition, triggering events are automaticallyassociated with those forms according to the protocol established forthe clinical trial so that the forms are made available only as certainevents occur within the systems of the IPI 100. The manner in which theresearch functionality of the present invention can be used to completeand submit those forms is described in more detail below.

By simplifying and facilitating the interactions between researchclients and research partners that are required to recruit researchclients and get patients enrolled in clinical trials, the presentinvention provides for completing the enrollment process for a clinicaltrial in a matter of days instead of months. Accordingly, healthcareproviders can quickly begin enrolling candidates, participating in theclinical trials, and receiving reimbursements form clinical trialsponsors or CROs via the functionality of the present invention. And, inaddition to recruiting research clients and enrolling patients forclinical trials, similar methods can also be utilized for recruitingresearch clients and enrolling patients for other types of medicalresearch, such as disease registries and quality of care initiatives.Thus, the functionality of the present invention eliminates many, if notall, of the hurdles put in place by HIPAA that otherwise deterhealthcare providers from participating in medical research.

In addition to the present invention's functionality for recruitingresearch clients and enrolling patients to participate in medicalresearch, the present invention also provides functionality for carryingout that research. Depending on the type of research being carried out,the present invention provides different functionality. For example, aresearch partner can use a template builder provided on one of thesystems of the IPI 100 or Form Manager software to generate the casereport forms (CRF) required to complete a clinical trial. The researchfunctionality of the present invention can then be used to retrieve,complete, and submit that form using the RFD form management standard.

In that example, the research partner or the IPI provider uses theresearch functionality of the present invention to pre-populate much ofthe data in those forms using the data stored on the various systems ofthe IPI 100. Those pre-populated forms are then transferred to aclinical trial sponsor's or CRO's EDC system for completion via datacapture at the point of care by an authorized physician, delegate,Principle Investigator (PI), and/or CRC conducting the clinical trial(i.e., the Form Filler). Rather than being retrieved, those documentsmay also be sent automatically to the EDC system based on a triggeringevent, such as a scheduled patient visit. After the forms are completedat the EDC system, they are submitted back to the clinical trial sponsoror CRO (i.e., the Form Receiver and/or Form Archiver) at an externalinformation system 142 or at their research system within the IPI 100for analysis and archiving.

Accordingly, the research functionality of the present inventionstreamlines data entry and shortens the time required by the authorizedphysician, delegate, PI, and/or CRC to complete those forms by allowingthem to retrieve, complete, and submit the required forms within asingle application. And, where the EDC systems has been integrated withthe systems of the IPI 100, data captured during the clinical trialsusing those EDC systems can be captured in real time within the IPI 100for use by the other systems of the IPI 100. Even where the EDC systemis not integrated with the other systems of the IPI 100, the IPI 100 canbe configured to consume that data.

In addition, the IPI 100 can also be configured to consume data from aCTMS. For example, the present invention can utilize the RetrieveProtocol for Execution Profile (RPE) integration standard to retrievethe clinical trial instructions (i.e., the trial protocol) from the CTMSsystem and execute them at the systems of the IPI 100 that will be usedto capture data for the clinical trial (e.g., EHR systems). Accordingly,the RPE integration standard can be utilized to integrate site-basedclinical research work flow into the task managers of EHR systems withinthe IPI 100 to automate scheduling and consume trial protocol documents.Thus, the RPE integration standard can be used to expand upon the amountsystem integration facilitated by the RFD form management standard. TheRPE integration standard is currently maintained by the IHE and itscontents are hereby incorporated by reference.

The present invention can also use the RFD form management standard toretrieve Adverse Event (AE) forms from local Institutional Review Boards(IRBs), to pre-populate data into those forms, and to submit those formsback to the IRBs, to the clinical trial sponsor or CRO, and to all othersites participating in the same clinical trial. AE forms are used toreport adverse changes in health or side-effects that occur in a patientparticipating in a clinical trial while the patient is receivingtreatment (e.g., receiving test medication, using a test medical device,etc.) or within a pre-defined period of time after their treatment iscompleted. And, because of the integrated functionality of the presentinvention, the completed AE forms can be quickly and efficientlycompleted and submitted to all of the necessary parties, particularlythe other research sites participating in the clinical trial.

The present invention can also use the RFD form management standard tosubmit forms to various safety/quality organizations (e.g., MGMA, AHRQ,NCQA, HEDIS, CMS, etc.) that track the performance of specifichealthcare providers and determine whether those healthcare providershave satisfied certain quality measures and therefore qualify forspecific certifications, accreditations, and/or incentives. For example,a healthcare provider can utilize that functionality to pre-populate theforms required by CMS to qualify for Pay for Performance (P4P) incentivepay under the Physician Quality Reporting Initiative (PQRI). Thehealthcare provider then completes any part of the form notpre-populated by the present invention and submits it to CMS.

Where the systems of the IPI 100 contain all of the information requiredto complete specific forms and an IPI user need not complete any part ofthat form, the present invention can also be configured to send thedefined data elements for each specific form to a central router orregistry in a batch or near real time feed. That feed effectivelycompletes the forms without any action by the IPI user other thancapturing the required data. Accordingly, IPI users can complete formsin real time as data is collected, which the associated IPI system willautomatically submit without any additional IPI user interaction. Thatfunctionality is particularly useful for quality initiatives thatrequire physicians to regularly complete and submit identical forms onquality measures for a variety of covered services.

The present invention can also use the RFD form management standard tosubmit forms to various public health organizations based on certaintriggering events. For example, when a user of an EHR system within theIPI 100 indicates that a child was born to a patient, that event willautomatically trigger the EHR system to retrieve the requiredregistration form from the local Department of Public Health. The EHRsystem will also pre-populate the form with the parent's demographicdata, the baby's date of birth, and any other information captured bythe EHR system, such as the baby's weight as measured by an electronicscale connected to the EHR system. After the registration form iscomplete by the EHR system user, the EHR system will automaticallysubmit the completed form back the local Department of Public Health ina format easily recognized and processed by that Department of PublicHealth.

Using all of the functionality described above and equivalents thereof,the present invention provides an integrated system for quickly,accurately, and seamlessly collecting, tracking, and analyzing medicaldata across a vast patient population. The present invention alsoprovides functionality for managing and coordinating care across acommunity of healthcare providers in different settings, which canreduce the costs of unnecessary emergency room visits, repeated labtests, and preventable hospitalizations. The system is particularlysuited for performing medical research because it providesinfrastructure and functionality for utilizing that data to moreeffectively and efficiently perform medical research, maintain diseaseregistries, track patient care for quality and safety initiatives, andperform composite clinical and financial analytics. Moreover, theinfrastructure and functionality of the present invention facilitate themeasurement and promotion of continued improvement in clinical care.

The foregoing description and drawings should be considered asillustrative only of the principles of the invention. The invention maybe configured in a variety of shapes and sizes and is not intended to belimited by the preferred embodiment. Numerous applications of theinvention will readily occur to those skilled in the art. Therefore, itis not desired to limit the invention to the specific examples disclosedor the exact construction and operation shown and described. Rather, allsuitable modifications and equivalents may be resorted to, fallingwithin the scope of the invention.

What is claimed is:
 1. A system for performing medical research over anextended computer network, the system comprising: an enhanced servicesserver built on the same architecture as a plurality of ElectronicHealth Record (EHR) systems, the plurality of EHR systems beingconfigured to capture patient data for a plurality of general patientsat a plurality of corresponding healthcare provider sites duringencounters with those patients, said plurality of EHR systems beingconfigured to capture and transmit the patient data in a common dataformat that specifies information to be collected and a format for theinformation to be collected, and the enhanced services server being inelectronic data communication with the plurality of EHR systems and theone or more research systems via a network connection and beingconfigured to transmit and receive the patient data in the common dataformat and to perform the steps of: identifying a plurality ofqualifying patients from among the plurality of general patients thatqualify for the medical research; electronically receiving the one ormore electronic documents in the common data format from a researchsystem via the network connection, the one or more electronic documentsincluding one or more first fields and one or more second fields forcompletion with patient data that is related to the medical research;automatically populating the one or more first fields in each of the oneor more electronic documents with patient data in the common data formatfor a corresponding one of the plurality of qualifying patients, thepatient data being related to the medical research and having beencaptured with at least one of the plurality of EHR systems duringprevious encounters with the plurality of qualifying patients;electronically transmitting the one or more electronic documents thatwere automatically populated with patient data for each of thequalifying patients to at least one EHR system via the networkconnection, the at least one of the plurality of EHR systems being usedto complete the one or more second fields in each of the one or moreelectronic documents with patient data related to the medical researchduring subsequent encounters with the plurality of qualifying patients;electronically receiving the one or more electronic documents from theat least one EHR system via the network connection, the one or moreelectronic documents electronically received from the at least one ofthe plurality of EHR systems having the one or more first fields and oneor more second fields completed; and electronically transmitting the oneor more electronic documents with the one or more first fields and oneor more second fields completed back to the research system via thenetwork connection.
 2. The system of claim 1, wherein the at least oneof the plurality of EHR systems includes Electronic Data Capture (EDC)software for completing the one or more second fields in each of the oneor more electronic documents.
 3. The system of claim 1, wherein theresearch system is interfaced with the enhanced services server via aninteroperability engine at the enhanced services server; and the patientdata related to the medical research is made available to the researchsystem in real time as it is captured with the at least one of theplurality of EHR systems.
 4. The system of claim 1, wherein the one ormore electronic documents are electronically transmitted, electronicallyreceived, electronically consumed, and automatically populated using theRetrieve Form for Data Capture (RFD) form management standard.
 5. Thesystem of claim 4, wherein the at least one of the plurality of EHRsystems performs as a form filler under the RFD form managementstandard; the research system performs as a form manager and a formarchiver under the RFD form management standard; and the enhancedservices server performs as a form filler and a form receiver under theRFD form management standard.
 6. The system of claim 1, wherein theenhanced services server identifies the plurality of qualifying patientsbased on criteria received from the research system via the networkconnection.
 7. The system of claim 1, wherein the enhanced servicesserver is further configured to perform the steps of: automaticallypopulating consent forms with language required by the Health InsurancePortability and Accountability Act (HIPAA) regarding patient data thatis protected under HIPAA; and electronically transmitting the populatedconsent form to the at least one of the plurality of EHR systems forreceiving consent from the plurality of qualifying patients to accessthose patients' patient-specific information, wherein at least one ofthe plurality of qualifying patient's patient-specific information willnot be automatically populated in the one or more first fields or theone or more second fields if consent is not received from thatqualifying patient.
 8. The system of claim 1, wherein the enhancedservices server is further configured to perform the step ofelectronically transmitting the one or more electronic documents thatwere automatically populated with patient data for each of thequalifying patients back to the research system via the networkconnection; and the research system is configured to electronicallytransmit the one or more electronic documents that were automaticallypopulated with patient data for each of the qualifying patients to oneor more external systems for the one or more second fields to becompleted and to receive the one or more electronic documents back fromthe one or more external systems with the one or more first fields andone or more second fields completed, the one or more external systemshaving EDC software for capturing patient data related to the medicalresearch during subsequent encounters with the plurality of qualifyingpatients.
 9. The system of claim 1, wherein the at least one of theplurality of EHR systems is further configured to automatically retrievethe one or more electronic documents for at least one of the pluralityof qualifying patients at a scheduled time for a subsequent encounterwith that qualifying patient, the one or more first fields in the one ormore electronic documents retrieved for that qualifying patient beingautomatically populated with patient data for that at least onequalifying patient that is related to the medical research.
 10. Thesystem of claim 1, wherein the research system includes Clinical TrialsManagement System (CTMS) software that generates clinical instructionsfor the medical research; and the enhanced services server consumes theclinical instructions and integrates them into tasks performed with theat least one of the plurality of EHR systems to automatically schedulesubsequent encounters with the plurality of qualifying patients.
 11. Thesystem of claim 10, wherein the Retrieve Protocol for Execution (RPE)integration standard is used to consume the clinical instructions andintegrate them into tasks performed with the at least one of theplurality of EHR systems.
 12. The system of claim 1, wherein theresearch system includes template builder and/or form manager softwarefor creating the one or more electronic documents and defining the oneof more first fields and one or more second fields in the one or moreelectronic documents.
 13. A method for performing medical research overan extended computer network, the method comprising the steps of:placing an enhanced services server in electronic data communicationwith a plurality of Electronic Health Record (EHR) systems and aresearch system via a network connection, the plurality of EHR systemsbeing configured to capture patient data for a plurality of generalpatients at a plurality of corresponding healthcare provider sitesduring encounters with those patients, said plurality of EHR systemsbeing configured to capture and transmit the patient data in a commondata format that specifies information to be collected and a format forthe information to be collected, and the enhanced services server beingbuilt on the same architecture as the plurality of EHR systems andconfigured to transmit and receive the patient data in the common dataformat; using the enhanced service server to identify a plurality ofqualifying patients from among the plurality of general patients thatqualify for the medical research; electronically receiving at theenhanced services server one or more electronic documents in the commondata format from the research system, the one or more electronicdocuments including one or more first fields and one or more secondfields for completion with patient data that is related to the medicalresearch; using the enhanced services server to automatically populatethe one or more first fields in each of the one or more electronicdocuments with patient data in the common data format for acorresponding one of the plurality of qualifying patients, the patientdata being related to the medical research and having been captured withat least one of the plurality of EHR systems during previous encounterswith the plurality of qualifying patients; electronically transmittingthe one or more electronic documents that were automatically populatedwith patient data for each of the qualifying patients from the enhancedservices server to the at least one of the plurality of EHR systems viathe network connection; using the at least one of the plurality of EHRsystems to complete the one or more second fields in each of the one ormore electronic documents with patient data related to the medicalresearch during subsequent encounters with the plurality of qualifyingpatients; electronically transmitting the one or more electronicdocuments from the at least one EHR system to the enhanced servicesserver via the network connection, the one or more electronic documentselectronically received from the at least one of the plurality of EHRsystems having the one or more first fields and one or more secondfields completed; and electronically transmitting the one or moreelectronic documents with the one or more first fields and one or moresecond fields completed from the enhanced services server back to theresearch system via the network connection.
 14. The method of claim 13,wherein the at least one of the plurality of EHR systems includesElectronic Data Capture (EDC) software for completing the one or moresecond fields in each of the one or more electronic documents.
 15. Themethod of claim 13, further comprising the step of using the enhancedservices server to make the patient data related to the medical researchavailable to the research system in real time as it is captured with theat least one of the plurality of EHR systems, wherein the researchsystem is interfaced with the enhanced services server via aninteroperability engine at the enhanced services server.
 16. The methodof claim 13, wherein the one or more electronic documents areelectronically transmitted, electronically consumed, and automaticallypopulated using the Retrieve Form for Data Capture (RFD) form managementstandard.
 17. The method of claim 16, wherein the at least one of theplurality of EHR systems performs as a form filler under the RFD formmanagement standard; the research system performs as a form manager anda form archiver under the RFD form management standard; and the enhancedservices server performs as a form filler and a form receiver under theRFD form management standard.
 18. The method of claim 13, wherein theenhanced services server identifies the plurality of qualifying patientsbased on criteria received from the research system via the networkconnection.
 19. The method of claim 13, further comprising the steps of:automatically populating consent forms with language required by theHealth Insurance Portability and Accountability Act (HIPAA) regardingpatient data that is protected under HIPAA; and electronicallytransmitting the populated consent form to the at least one of theplurality of EHR systems for receiving consent from the plurality ofqualifying patients to access those patients' patient-specificinformation, wherein at least one of the plurality of qualifyingpatient's patient-specific information will not be automaticallypopulated in the one or more first fields or the one or more secondfields if consent is not received from that qualifying patient.
 20. Themethod of claim 13, further comprising the steps of: electronicallytransmitting the one or more electronic documents that wereautomatically populated with patient data for each of the qualifyingpatients from the enhanced services server back to the research systemvia the network connection; electronically transmitting the one or moreelectronic documents that were automatically populated patient with datafor each of the qualifying patients from the research system to one ormore external systems for the one or more second fields to be completed;completing the one or more fields in the one or more electronicdocuments with patient data related to the medical research duringsubsequent encounters with the plurality of qualifying patients, the oneor more external systems having EDC software for capturing that patientdata; and transmitting the one or more electronic documents from the oneor more external systems back to the research system via the networkconnection, the one or more electronic documents transmitted back to theresearch system having the one or more first fields and one or moresecond fields completed.
 21. The method of claim 13, further comprisingthe step of using the at least one of the plurality of EHR systems toautomatically retrieve the one or more electronic documents for one ofthe plurality of qualifying patients at a scheduled time for asubsequent encounter with that qualifying patient, the one or more firstfields in the one or more electronic documents retrieved for thatqualifying patient being automatically populated with patient data forthat qualifying patient that is related to the medical research.
 22. Themethod of claim 13, further comprising the steps of: generating clinicalinstructions for the medical research with Clinical Trials ManagementSystem (CTMS) software at the research system; and using the enhancedservices server to consume the clinical instructions and integrate theminto tasks performed with the at least one of the plurality of EHRsystems to automatically schedule subsequent encounters with theplurality of qualifying patients.
 23. The method of claim 22, whereinthe Retrieve Protocol for Execution (RPE) integration standard is usedto consume the clinical instructions and integrate them into tasksperformed with the at least one of the plurality of EHR systems.
 24. Themethod of claim 13, further comprising the step of using templatebuilder and/or form manager software at the research system to createthe one or more electronic documents and define the one of more firstfields and one or more second fields in the one or more electronicdocuments.